The invention relates to a guidewire and a rotation preventer for facilitating antegrade catheterization of the superficial femoral artery (SFA) and to a method for inserting a guidewire into the SFA.
For introducing a catheter into the SFA, first the common femoral artery (CFA) is pierced with a vascular access needle. Next, a guidewire is inserted via the needle into the CFA and then manipulated so as to enter the SFA. This is followed by withdrawing the vascular access needle, leaving the inserted guidewire in place. Next, an introducer passing over and covering sections of the guidewire is inserted into the CFA and, guided by the guidewire, into the SFA. The guidewire is then withdrawn, leaving the introducer in the blood vessel, via which a catheter or other device for vascular intervention in a lower limb can be introduced into the SFA to the section of the SFA to be treated.
A particular problem associated to the introduction of a guidewire into the SFA is that the position where the arteries are close to the skin, allowing the needle to be reliably pierced through the skin and into the artery, is located nearby and on a side opposite of the position where the deep femoral artery (DFA) branches off from the CFA. More in particular, the position of the point of entry of the needle is dictated by requirements concerning access, staying clear of the abdominal cavity and the presence of bony tissue closely behind the artery allowing to clamp off the CFA in the event of bleeding and it cannot be seen from the outside of the patient what the distance is between the point of entry and the bifurcation of the CFA into the DFA and the SFA (see Antegrade Puncture of the Femoral Artery: Morphologic Study (Spijkerboer A. M., Scholten F. G., Mali W. P., Van Schaik J. P.; Radiology 1990 July; 176(1):57-60)). Accordingly, particular care and skill are required to manipulate the guidewire such that it enters the SFA.
The need of prolonged manipulation to gain access to the SFA is particularly disadvantageous, because fluoroscopic monitoring of the movements of the guidewire near the puncture area involves irradiating an area close to the area where the hands of the operator operating the needle and the guidewire are located, which entails repeated exposure of body parts of operators who regularly perform ante grade catheterization of the SFA. Many solutions have been proposed to facilitate leading a guidewire into the SFA.
In “A New Antegrade Femoral Artery Catheter Set” (Kikkawa K.; Radiology 1984 June; 151(3):798) a catheter needle set is described, which includes a polyethylene catheter sheath with a 30° angled tip and a steering device at the base for torque control. Introduction of this sheath into the SFA requires several test injections of contrast medium and a very subtle manipulation of the sheath under fluoroscopy guidance.
In “A New Catheter Configuration for Selective Antegrade Catheterization of the Superficial Femoral Artery: Technical Note” (Bohndorf K. Gunther R. W.; Cardiovasc Intervent Radiol. 1991 March-April; 14(2):129-31) a special polyethylene catheter with a very short (4 mm), 90° angled tip and one small side hole is proposed. After puncture of the CFA, a J-guidewire is introduced and the special catheter is advanced over the guidewire until the angled tip is in the CFA. Under fluoroscopic control and using small amounts of contrast medium this catheter is gently manipulated in the CFA until the tip is aligned with the CFA and directed towards the SFA. Then the SFA entrance is visualized and a guidewire with long floppy end is introduced via the catheter and directed into the SFA by the angled tip.
A needle having a curved distal end (J-needle) for directing a guidewire into the SFA is described in “A New Puncture Needle (Vascular access Technique) for Easy Antegrade Catheterization of the Superficial Femoral Artery” (Saltzman J., Probst P.; Eur J. Radiol. 1987 February; 7(1):54-5).
Also in “Directional Needle for Antegrade Guidewire Placement with Vertical Arterial Puncture” (Hawkins J. S., Coryell L. W., Miles S. G., Giovannetti M. J., Siragusa R. J., Hawkins I. F. Jr.; Radiology. 1988 July; 168(1):271-2) a needle for directing the guidewire to the SFA is proposed. The needle has a closed pencil-point tip and a distal side hole. This technique requires very subtle needle retraction, needle rotation and needle removal, fluoroscopic control, and the use of contrast medium in order to allow a guidewire to advance into the SFA.
In “Double-Guide-Wire Access through a Single 6-F Vascular Sheath” (Teitelbaum G. P., Joseph G. J., Matsumoto A. H., Barth K. H.; Radiology. 1989 December; 173(3):871-3), it is described to introduce a 6-F vascular sheath into the DFA over a 3 mm J-guidewire. This sheath is slowly withdrawn while injecting small amounts of contrast medium until its distal tip lies just proximal to the femoral bifurcation. Subsequently a second steerable guidewire (Glidewire) is manipulated through the sheath into the SFA; then the J-guidewire is removed and the sheath advanced into the SFA.
One technique described in “A Comparison of a ‘J’ Wire and a Straight Wire in Successful Antegrade Cannulation of the Superficial Femoral Artery” (Gay D. A., Edwards A. J., Puckett M. A., Roobottom C. A.; Clin Radiol. 2005 January; 60(1):112-5), is to introduce a 3 mm J-guidewire after standard antegrade puncture of the CFA with its tip facing anteriorly promoting passage into the SFA. However, in 6 of 25 patients in the experiment the guidewire did not enter the SFA correctly in the initial pass.
In spite of all efforts, a reliable technique for SFA canulation after antegrade CFA puncture and without monitored manipulation is still lacking. In view of the problems associated with antegrade CFA puncture, some centers recently advocated the use of ultrasound-guidance to assist in antegrade CFA puncture and SFA canulation. Also, the difficulties with antegrade catheterization of the SFA have led to the development of techniques for gaining access to the SFA via retrograde CFA puncture. All these reversal techniques in fact convert an ipsilateral retrograde puncture to antegrade catheterization. These techniques require a substantially longer screening time resulting in a higher radiation exposure than ante grade puncture techniques. In addition reversal may induce a greater stretch on the punctured vessel wall leading to hemorrhagic complications.